Atovaquone and Proguanil Hydrochloride

Product NDC
60760-498
11-digit product format
607600498
Labeler code
60760
Product ID
60760-498_b699e059-0bf3-7a47-e053-2a95a90a2916
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atovaquone and Proguanil Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
St. Mary's Medical Park Pharmacy
Application
ANDA091211
Marketing category
ANDA
Marketing start
2011-08-18
Marketing end
0000-00-00
Substance
ATOVAQUONE; PROGUANIL HYDROCHLORIDE
Active strength
250 mg/1; mg/1
Pharmacologic classes
Antimalarial [EPC],Antiprotozoal [EPC],Antimalarial [EPC],Dihydrofolate Reductase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60760-498-04EA - Each60760-4987b395df3-809f-48b9-a91e-f86657f4796e12017-03-06
60760-498-11EA - Each60760-4987478a156-62c9-43ea-94f8-20f7268d627f12017-03-06
60760-498-13EA - Each60760-498a52b400e-4870-4dfe-8f24-63d2cabad42712017-03-06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60760-498-04607600498044 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-498-04) 2016-08-010000-00-00NoNoCurrent
60760-498-116076004981111 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-498-11) 2016-08-010000-00-00NoNoCurrent
60760-498-136076004981313 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-498-13) 2016-08-010000-00-00NoNoCurrent